Biosimilars in Ophthalmology: Challenges, Access, and Patient Assistance Programs

Rishi P. Singh, MD: What are the challenges you think are facing ophthalmologists and retina specialist in regard to adopting biosimilars as it stands right now?

Michael A. Klufas, MD: Very good question. I think biosimilars are still pretty new. We’ve heard about them in the meetings maybe for the past 2 to 3 years, but they are here now and out for almost a whole year. I think in retina, especially with vision, we treat a lot of vision-threatening complications, vascular disease; we always have some pause injecting something new into the eye. So I think that first injection is really the biggest barrier for an established retina specialist, especially because we have such products that that are great and work well, and we want to do what’s best for that individual patient in our chair. However, I would say education on biosimilars, as we’re doing here, [and] looking at the data, this is not a study that involved 100 patients, there are 500 patients in the study. They’re looking at drug immunogenicity to show that it actually shows the same response to the reference product. They also look at drug antibodies. All these are very similar and really, at the heart of it, it’s the same amino acid sequence. And ranibizumab is actually like a pretty simple amino acid sequence from the basic scientists I’ve talked to, so it’s probably favorable that we started with something that’s relatively on the easier side to manufacture. But I think once you have that first patient and a good outcome, then you start having confidence in using it more in the future. But that first injection I think is a little bit tough for some established retina specialists.

Rishi P. Singh, MD: Yeah, I think you’re right, I think that there’s this wariness. With all the information that’s been out there in the past couple years on various drugs, they’re just a little bit wary about adopting a new drug, and I agree with you. I think these drugs have been shown thus far. There have been some nice studies already done and presented at some of our major meetings, which have shown that thousands of injections of these have been done in practice without any significant intraocular inflammation events or anything else that’s a really major concern. So I’m glad to see that that has come to fruition for those drugs so far. [Let’s talk] a little bit about the insurance coverage. Are you running into any insurance issues? I can tell you a little bit about our practice in Ohio. Our practice in Ohio has recently faced some challenges in regard to using a biosimilar as an option following…ranibizumab and then going through a branded drug. So we had to adopt a biosimilar as a result of that. Are you facing similar challenges in regard to insurance in your area?

Michael A. Klufas, MD: Yes, I think that it’s quite variable with the insurers. Obviously in the neovascular AMD [age-related macular degeneration] population, like a regular Medicare patient, you really have choice to use typically whatever you want, whether that’s off-label bevacizumab, a ranibizumab biosimilar, or another branded medication. For other insurers, yes, one issue we’ve encountered is [that] someone may have been on reference ranibizumab since, say, 2016 for maintenance of age-related macular degeneration…. Now we have a biosimilar, and we’re more than willing to be cost-conscious and switch to that medication. But a lot of insurers have step therapy now, which didn’t exist in 2016, and so they’ll look historically and say, “Well, this patient never received off-label bevacizumab. We’d like you to restart step therapy,” which kind of creates an interesting situation for a patient and physician; should you go back to step therapy and try to get a biosimilar, or should you just continue with the reference product? But I think insurers are not only focused on ophthalmology; they have oncology and rheumatology. So we are a major cost center, but all those details haven’t been figured out. So I see evolving policies over time. And we’ve gone to some insurers and said, “Look, this is an interchangeable product. Can we please use this?” And they said, “Oh, interchangeability, great. Now we understand what the FDA means, and we do approve this.” So some with education [they] will be willing to allow a switch.

Rishi P. Singh, MD: I’ll add to that. I think that our biggest challenge in our patient population is retention of them on therapy, right? If we had to look at it, I mean, even if we gave a drug frequently every other month as we were doing kind of in practice right now, the average is around 8 to 9 weeks per retina specialist. As long as it was a low-cost option for our patients, we might actually be able to retain them, albeit that would still give the same durability from the injection profile. And that [would] certainly be a way to improve outcomes overall for our populations. What about patient assistance and reimbursement support programs available for biosimilars? Are you aware of any that are helpful to you or are there things you’re using in your practice right now for others to know about?

Michael A. Klufas, MD: I think the easiest one to tackle is the patient assistance programs. They are essentially equivalent to what you’ve been used to with other manufacturers. Many of these manufacturers contribute to different funds that allow patients who meet financial need to have assistance if needed or if they’re uninsured. These programs are very similar in some cases, [offering] even less of a co-pay for patients. So I’ve seen very strong support there, and it’s great to have those for our patients to have options. With regard to reimbursement, one interesting thing I’ve seen is, even when the biosimilars first come to market with biologics for intravitreal injection, typically they have a J code. Well, biosimilars have a Q code, and from a billing standpoint, I would say we’ve had some of the highest confidence.

Rishi P. Singh, MD: And the Q codes I think are helpful to us as practices to improve the billing efficiency which we’re used to in the J code model. And I think that will obviously increase the adoption. As you said, like the hesitancy, the adoption had been around that sometimes for that. And we know that the reimbursement models are out there now so they can help with that as well. And certainly co-pay assistance and patient assistance, hub services programs that you mentioned before, incredibly valuable chronic disease funds that we tap into sometimes free drugs for those who are in the injured in populations of people adding around the poverty rates can be very helpful too. And they have all those available for all the biosimilars which are out there right now.

Transcript is AI-generated and edited for clarity and readability.